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Two Firms Stopped From Making Unapproved Drugs

FDA takes action over untested pharmaceuticals

April 13, 2009

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The Food and Drug Administration has received a court order stopped two companies from making and distributing unapproved, adulterated or misbranded drugs. The agency took the action against Neilgen Pharmaceuticals Inc. of Westminster, Md., its parent company, Advent Pharmaceuticals, Inc., of East Windsor, N.J., and two of their officers.

Both Neilgen, which does business as Unigen Pharmaceuticals Inc., and Advent are contract manufacturers and distributors of more than 25 different unapproved drug products each.

The more than 50 unapproved drug products primarily include prescription cough and cold products. The unapproved drugs manufactured by Unigen and/or Advent include, but are not limited to:

• RE All 12 Suspension;

• BP Allergy Junior Suspension;

• PE Tann 20 mg/CP Tann 4 mg Suspension;

• BP New Allergy DM Suspension;

• D-Tann CT Tablets;

• B-Vex D Suspension;

• Histex SR; and

• Chlorpheniramine Maleate 12 mg/Pseudoephedrine HCl 120 mg LA Tablets.

The agency said the unapproved drugs made by these companies have not undergone the FDA's drug approval process, so their safety and effectiveness have not been established. In addition, FDA said it has not reviewed the adequacy and accuracy of the directions for use and warnings on the labeling.

Consumers who have any of these products should stop using them and discuss FDA-approved treatments with their health care professional. Pharmacists should stop dispensing them, the agency advised.

"To protect the American public, companies that continue to market unapproved drugs must be required to cease that illegal activity," said Janet Woodcock, M.D., director, the FDA's Center for Drug Evaluation and Research. "It is critical that only drugs that are safe, effective and manufactured in accordance with good manufacturing practices be allowed into the U.S. marketplace."

The companies have signed a consent decree that orders them to destroy their existing drug supply, and prohibits them from commercially manufacturing and distributing any new drugs without the FDA's approval.

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